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Pro-forma checklist to assist with preparing an ethics application (MS Word Document - 164.4 KB)

To assist with preparing a research governance / Site Specific Assessment (SSA) application (MS Word Document - 772.1 KB)

For each research project that has a site in Victoria, the Victorian Specific Module (VSM) must be completed and submitted to the reviewing Human Research Ethics Committee (HREC) as part of the ethics application. (MS Word Document - 69.2 KB)

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This paper provides guiding principles to optimise digital technology for executing CTRAs using eSignatures. (PDF File - 236.3 KB)

This document provides background information and guidance for a scientific expert reviewer to conduct scientific review, at the request of an ethics committee in Victoria, regarding early phase clinical trials. (PDF File - 2.5 MB)

This document provides details and contact information for organisations taking part in the National Mutual Acceptance (NMA) initiative. (PDF File - 352.7 KB)

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This document aims to provide an overview of the various legislative and administrative frameworks that currently exist in Commonwealth, States and Territories and apply to the approval of human research under Mutual Acceptance of Ethics and Scientific Review. This document is not a substitute for legal advice. (PDF File - 334.6 KB)

This matrix is designed to assist investigators, HREC Coordinators and Research Governance Officers. It provides information on reporting requirements for multi-centre human research projects taking place in Australia. (MS Excel Document - 437.9 KB)

Arrangements for ethics and research governance/Site Specific Assessment (SSA) applications across the NMA jurisdictions are described in this NMA Ethics and Governance Matrix table. (PDF File - 187.8 KB)

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The National Mutual Acceptance (NMA) scheme has been revised to better support researchers undertaking multi-jurisdiction studies involving linkage of data. (MS Word Document - 156.1 KB)

Additional supporting documents that address state legislation e.g. Western Australian Specific Module (WASM) and Victorian Specific Module (VSM) may be required for some research projects. (MS Word Document - 140.2 KB)

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The purpose of this document is to provide guidance to assist all sectors involved in clinical trials to understand the processes used to meet the regulatory requirements for clinical trial research in Australia. (PDF File - 1.1 MB)

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These guidelines provide useful information and specific instructions for completing Sections 1, 2 and 3 of the Victorian Specific Module. (PDF File - 351.8 KB)

For each research project that utilises the Human Research Ethics Application (HREA) form and has a site in Victoria, the Victorian Specific Module (VSM) must be completed and submitted to the reviewing Human Research Ethics Committee (HREC) as part of the ethics application. (PDF File - 424.7 KB)

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For an Investigator Initiated Study (MS Word Document - 53.2 KB)

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Template letter to use if Ionising radiation exposure in a research project is not considered to be additional to normal clinical management/care at the site and the reviewing HREC is in Victoria (MS Word Document - 21.0 KB)

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The Stand Alone Teletrial PICF is used for an approved trial when a teletrial will be added to the existing trial, instead of amending a Master PICF.  This is used for the added Satellite Site(s). (MS Word Document - 48.0 KB)

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